LAPTOP (The Late Presenter Treatment Optimisation Study)

To compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection.

An Open-Label, Multi-Centre, Randomized Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV-Disease

Key Eligibility Criteria

1. Ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements

2. ≥ 18 years

3. HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/µL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/µL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)

4. Have an entry HIV viral load > 1000 copies/mL

5. Able to take oral medications

6. ART-naïve prior to study enrolment

7. Willing to use acceptable methods of contraception

Therapeutic Area

HIV

Type of Study

Clinical trial PHASE IIIB

Sponsor

NEAT ID Foundation

Principal Investigator

Professor Paddy Mallon

Contact

Binita.maharjan@ucd.ie